With added emphasis on science based risk management and the reliance on technical experts to assist in the assessment process pharmaceutical manufacturing is becoming increasingly automated. That means Good Automated Manufacturing Practice (GAMP) is more relevant than ever. As the hardware and software evolves, GAMP evolves accordingly.

Generally, the more specialized the software, the greater the risk, particularly from user error. However, opportunities now exist to leverage contributions from suppliers and vendors in the implementation of regulated computer systems.

With proper controls and oversight this can enable many life cycle and validation activities to be completed more efficiently while maintaining a high level of compliance.

Mr. Gaurav Walia will walk you through the history of GAMP, including the transition to GAMP 5 and the changes in categorization. He’ll detail the top three challenges in implementing GAMP, the typical issues of legacy systems, key laboratory examples, and the top trends in consent decrees related to GAMP. He’ll conclude with a discussion of upcoming GAMP-related publications expected from the FDA and others.

At the conclusion of this presentation you’ll have the foundation for developing and establishing a compliant and effective computer system validation framework.